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NCT02885454 · ClinicalTrials.gov registry record · Phase 1
To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02885454: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02885454 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02885454, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy female participants.
Primary Outcome
Cmax is the maximum observed analyte concentration.
Interventions
- DRUG Odalasvir (ODV)
- DRUG Simeprevir (SMV)
- DRUG Drospirenone/ethinylestradiol
- DRUG AL-335
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-08 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT02885454 record still lists
NCT02885454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Odalasvir (ODV) is the first listed.
NCT02885454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02885454 about?
NCT02885454 is a clinical study titled "To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants". The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy...
What is the current status of trial NCT02885454?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-08. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02885454?
The interventions under investigation include: Odalasvir (ODV) (DRUG), Simeprevir (SMV) (DRUG), Drospirenone/ethinylestradiol (DRUG), AL-335 (DRUG).
Who is sponsoring clinical trial NCT02885454?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02885454's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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